标准摘要
[中文适用范围]： 本文件规定了用于牙科的医疗器械生物效应评价的试验方法。它包括作为被测设备组成部分的药物制剂的测试。 本文件不涵盖与患者身体无直接或间接接触的材料和设备的测试。 [外文原描述]： ISO 7405 provides a set of biological test methods to evaluate the biocompatibility of medical devices used in dentistry . These tests help determine whether a device or material that comes into direct or indirect contact with a patient’s body is safe for use. ISO 7405 is designed to be used in conjunction with the ISO 10993 series, which provides more general guidance on biological evaluation of medical devices.
英文名称Dentistry — Evaluation of biocompatibility of medical devices used in dentistry